1. Field of the Invention
The present invention relates to pharmaceutical compositions useful for the prevention and/or treatment of peptic ulcer diseases. More particularly, it relates to the use of American ginseng or the extract thereof as the active ingredient for the prevention and treatment of peptic ulcer diseases.
2. Description of the Related Arts
American ginseng (Panax quinquefolium L.) is one species of Araliaceae, which is the North American variety of ginseng native to the United States and Canada. The Panax plants in Araliaceae, such as Panax ginseng, Panax quinquefolium, Panax pseudo-ginseng etc, have been used as a form of tonic medicine in Chinese for a long period of time, and Panax ginseng is traditionally considered a valuable medicinal material in China, Japan and Korea. After harvesting, Panax ginseng with good quality is generally treated with boiling water or steam to give red ginseng. Panax ginseng which has been dried by hot air or sunlight is called white ginseng or unprocessed ginseng. The American ginseng is an herbaceous perennial and its root is mainly used as a nutritious tonic agent. Its morphology is similar to Panax ginseng, but has less fiber-like or lateral roots. At present, the American ginseng is artificially cultivated in the United States, Mainland China and Russia. Many reports have shown some components of American ginseng are similar co Panax ginseng, including several kinds of ginseng saponins, oligosaccharides, volatile oils, amino acids, vitamins and trace elements. It is traditionally believed that both American ginseng and Panax ginseng possess effects of increasing physical strength, nourishing and preserving health, and prolonging life. Thus, they are regarded as mild tonics used for daily dietary or medicinal remedy.
Recently, a number of scientific reports show that the American ginseng indeed possesses a variety of physiological or pharmaceutical activities, including anti-aging (Xiao P.G. et. al., 1993, Journal of Ethnopharmacology 38(2-3):167-75); preventing atherosclerosis and hyperlipidemia (Li J. et. al., 1999, Life Science 64(1):53-62); protecting liver from injury (Yoshikawa M. et. al., 1998, Chemical and Pharmaceutical Bulletin 46(4):647-54); enhancing the function of cardiovascular system (Kwan C. Y., 1995, Clinical and Experimental Pharmacology and Physiology-Supplement 1:S297-9; Yang S., 1992, China Journal of Chinese Material Medica 17(9):555-7 and U.S. Pat. No. 4,708,949); preventing memory dysfunction and dementia (Benishin C. G., 199;, Pharmacology 42(4):223-9; Li Z. et. al., 1999, Journal of Pharmacy and Pharmacology 51(4):435-40; Lewis R. et. al., 1999, Phytotherapy Research 13(1):59-64); decreasing hyperglycemia (Oshima Y. et. al., 1987, Journal of Natural Products 50(2):188-90; Martinez S. and Staba E. J., 1984, Japanese Journal of Pharmacology 35 (2):79-85); inhibition of breast cancer cells (Duda R. B. et. 2a., 1996, Annals of Surgical Oncology 3(6):515-20); enhancing physical strength; antiviral activity (U.S. Pat. No. 5,071,839); anti-oxidation; decreasing the side effects of anticancer chemotherapy and radiotherapy (U.S. Pat. No. 4,945,115); modulating gastric digestion (Yuan C. S. et. al., 1998, American Journal of Chinese Medicine 26(1):47-55); and increasing the immune function (U.S. Pat. No. 4,795,742) etc.
Recently, the population with gastrointestinal diseases has been increasing, especially in highly developmental countries. The causes of peptic ulcers include unrelieved daily pressure; excessive alcohol irritation; the side effects of drugs, such as aspirin or non-steroid anti-inflammatory drugs; or Helicobacter pyroli infection. The predominant drugs used to treat peptic ulcers include muscarinic antagonists, such as methscopolamine bromide; H2 blockers, such as cimetidine; antacids, such as aluminum hydroxide or magnesium hydroxide; H+/K+ATPase inhibitor, such as omeprazole; anti-bacterial drugs, such as admixture of amoxicillin and metronidazole. Such drugs may be classified into two categories: one is used for physical protection of gastric mucosa to mitigate the irritation of the gastric acid to the mucosa ulcer site; the other is used for chemically inhibiting the secretion of the gastric acid, to avoid ulceration produced from excessive gastric acid erosion. The prevalence of peptic ulcers and their high rate of recurrence may due to patients"" life style or season change and many patients repeatedly suffer from peptic ulcers. Thus, there is a need for a safe, mild and effective drug for treating and preventing peptic ulcers.
It is an object of the present invention to provide pharmaceutical compositions which are effective in preventing and/or treating peptic ulcer diseases, comprising an effective amount of American ginseng and/or the extract thereof, and a physiologically or pharmaceutically acceptable carrier.
An additional object of the present invention is to provide a process of preparing the extracts of the American ginseng described above, comprising the steps of (a) extracting American ginseng with a solvent with a polarity higher than 0.88 to obtain an extract; (b) filtering the extract to obtain a filtrate; and (c) centrifuging the filtrate to obtain a supernatant (total extract).
The preparation process according to the present invention may further comprise the means of ultrafiltrating, dialyzing, precipitating with ethanol, or performing reverse phase chromatography, to obtain certain fractions of American ginseng extract.
Another object of the present invention is to provide methods for preventing and/or treating a patient suffering from peptic ulcer, comprising administrating an effective amount of American ginseng and/or the extracts thereof to said patient.